Stéphane Bancel, Moderna CEO (Adam Glanzman/Bloomberg via Getty Images)

UP­DAT­ED: Mod­er­na says Covid-19 boost­ers stand a fight­ing chance against new vari­ants

A day be­fore its sec­ond an­nu­al Vac­cines Day, Mod­er­na has post­ed an up­date on its crown jew­el, in­clud­ing a 6-month look at the Covid-19 shot and new pre­clin­i­cal da­ta that sug­gest its boost­er can­di­dates stand a fight­ing chance against new vari­ants.

Mod­er­na’s vari­ant-spe­cif­ic boost­er mR­NA-1273.351, which was de­signed to tar­get the B.1.351 mu­ta­tion first iden­ti­fied in South Africa, “closed the neu­tral­iz­ing titer gap for vari­ants of con­cern” in mice, the com­pa­ny said on Tues­day af­ter­noon. When giv­en at the 6-month mark, the boost­er elicit­ed neu­tral­iz­ing titers against the vari­ant that were com­pa­ra­ble to those pro­duced against the orig­i­nal virus.

mR­NA-1273.211, a com­bi­na­tion of mR­NA-1273.351 and Mod­er­na’s al­ready au­tho­rized vac­cine, al­so in­creased neu­tral­iz­ing titers against vari­ants ac­cord­ing to the pre­clin­i­cal re­sults, which have been sub­mit­ted to bioRx­iv but haven’t been pub­lished.

“The new pre­clin­i­cal da­ta on our vari­ant-spe­cif­ic vac­cine can­di­dates give us con­fi­dence that we can proac­tive­ly ad­dress emerg­ing vari­ants,” CEO Stéphane Ban­cel said in a state­ment. “Mod­er­na will make as many up­dates to our COVID-19 vac­cine as nec­es­sary un­til the pan­dem­ic is un­der con­trol.”

Ban­cel told End­points News that he ex­pects the virus to mu­tate very quick­ly in the next cou­ple years, be­cause a lot of peo­ple haven’t yet been vac­ci­nat­ed or in­fect­ed. Then in 2023 or 2024, he pre­dicts the speed at which the vac­cine mu­tates could slow down.

“We think that in the next two years, there might be a need for sev­er­al boosts, es­pe­cial­ly for peo­ple at high risk,” he said. “We think over time, maybe a boost per year might be enough, es­pe­cial­ly if com­bined with your flu boosts.”

As for the orig­i­nal vac­cine, an up­dat­ed re­view of 900-plus Covid-19 cas­es from the Phase III COVE study con­firms the jab is more than 90% ef­fec­tive against all cas­es, and over 95% ef­fec­tive against se­vere cas­es. A study with 33 Phase I par­tic­i­pants showed that an­ti­bod­ies per­sist­ed 6 months af­ter the sec­ond dose, ac­cord­ing to re­sults pub­lished in the New Eng­land Jour­nal of Med­i­cine. Mod­er­na be­lieves ef­fi­ca­cy kicks in two weeks af­ter the sec­ond dose.

As part of its own up­dat­ed re­view, Pfiz­er said its BioN­Tech-part­nered jab demon­strat­ed “strong pro­tec­tion” 6 months af­ter the sec­ond dose, with an over­all ef­fi­ca­cy rate of 91.3%.

Mod­er­na’s Phase II/III Teen­COVE study is ful­ly en­rolled with about 3,000 par­tic­i­pants be­tween the ages of 12 and 17 in the US, ac­cord­ing to the com­pa­ny. That tri­al will as­sess a 100 µg dose of the vac­cine. Mean­while, the Phase II/III Kid­COVE study is still re­cruit­ing chil­dren be­tween 6 months and 11 years old. Mod­er­na hopes to en­roll 6,750 healthy par­tic­i­pants in the US and Cana­da for the two-part dose es­ca­la­tion study. In Part 1, chil­dren be­tween the ages of 2 and 12 will re­ceive ei­ther 50 μg or 100 μg of the vac­cine, and those who are younger will be giv­en one of three dose lev­els — 25 μg, 50 μg or 100 μg. An in­ter­im analy­sis will de­ter­mine which dose is used in Part 2.

The news comes as the US paus­es the roll­out of J&J’s vac­cine to re­view da­ta around six re­port­ed cas­es of a rare and se­vere type of blood clot. The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices is meet­ing to­mor­row to fur­ther re­view these cas­es and as­sess their po­ten­tial sig­nif­i­cance.

The EMA re­port­ed 3 cas­es of cere­bral ve­nous si­nus throm­bo­sis among the 4.5 mil­lion peo­ple vac­ci­nat­ed with J&J’s shot world­wide. By com­par­i­son, 169 cas­es of CVST and 53 cas­es of splanch­nic vein throm­bo­sis were re­port­ed among 34 mil­lion peo­ple who re­ceived the As­traZeneca vac­cine in the EEA and UK. Thir­ty-five CVST cas­es were found world­wide among those who have re­ceived the Pfiz­er shot, and 5 for Mod­er­na.

“A com­pre­hen­sive as­sess­ment of the to­tal­i­ty of the avail­able safe­ty da­ta for mR­NA-1273 af­ter over 64.5 mil­lion dos­es ad­min­is­tered glob­al­ly does not sug­gest an as­so­ci­a­tion with CVST or throm­bot­ic events, based on analy­ses per­formed us­ing da­ta through March 22, 2021,” Mod­er­na said in a state­ment.

The CDC has is­sued a state­ment that its Vac­cine Ad­verse Event Re­port­ing Sys­tem “has re­ceived no re­ports of CVST with throm­bo­cy­tope­nia among per­sons who re­ceived ei­ther of the two mR­NA-based COVID-19 vac­cines.”

As of April 12, Mod­er­na had shipped out 132 mil­lion dos­es world­wide, in­clud­ing about 117 mil­lion to the US. Rough­ly 88 mil­lion dos­es were de­liv­ered to the US in Q1, in ad­di­tion to about 14 mil­lion else­where. Plans are in place to ramp up the com­pa­ny’s ex-US sup­ply chain.

Mod­er­na says it’s on track to de­liv­er 100 mil­lion dos­es to the US by the end of May, and an­oth­er 100 mil­lion by the end of Ju­ly.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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